US20010049519A1 - Integral hub and strain relief - Google Patents
Integral hub and strain relief Download PDFInfo
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- US20010049519A1 US20010049519A1 US09/888,920 US88892001A US2001049519A1 US 20010049519 A1 US20010049519 A1 US 20010049519A1 US 88892001 A US88892001 A US 88892001A US 2001049519 A1 US2001049519 A1 US 2001049519A1
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- Prior art keywords
- strain relief
- hub
- accordance
- hub assembly
- distal end
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C70/00—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
- B29C70/68—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts by incorporating or moulding on preformed parts, e.g. inserts or layers, e.g. foam blocks
- B29C70/72—Encapsulating inserts having non-encapsulated projections, e.g. extremities or terminal portions of electrical components
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0097—Catheters; Hollow probes characterised by the hub
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
- B29C45/14598—Coating tubular articles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M2025/0098—Catheters; Hollow probes having a strain relief at the proximal end, e.g. sleeve
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7542—Catheters
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Anesthesiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Mechanical Engineering (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Composite Materials (AREA)
- Manufacturing & Machinery (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
A hub assembly for a catheter tube having a lumen therethrough. The hub assembly includes a hub portion having a proximal end and a distal end, and an integral connector disposed at the proximal end. A lumen is defined through the hub portion extending from the proximal end to the distal end. The strain relief includes a proximal end and a distal end is disposed at the distal end of the hub portion. The proximal end of the strain relief can be integrally connected to the distal end of the hub portion. The strain relief is preferably more flexible than the hub portion. The strain relief defines a passage configured to receive the catheter such that a lumen through the hub portion is in fluid communication with the catheter tube lumen.
Description
- The present invention pertains generally to the field of catheters and, more particularly, to hub or manifold assemblies connected to the proximal end thereof.
- Catheters, such as guide catheters, diagnostic catheters and therapeutic catheters, for example, angioplasty and atherectomy catheters generally comprise a flexible tube having a permanently connected hub assembly at one end of the tube. The hub assembly often includes a hub and a strain relief. The hub generally includes a connector for connecting the catheter to a Y-adaptor, inflation device or the like. The strain relief generally extends from the hub along a portion of the catheter tube to provide a transition in flexibility between the hub and the tube.
- Prior hub assemblies utilized a two piece construction, for example, the hub was attached to an end of the catheter tube and then the strain relief was attached in a secondary process. The primary reason for the two piece design was the different functions of the hub and strain relief required different materials or material properties. The hub is required to be harder material to withstand forces applied to the connector. The strain relief, however, must provide a stiffness transition from the hub to the catheter shaft. The strain relief material is typically soft and flexible to provide kink-resistance and added support to the catheter shaft proximate the hub.
- One such hub assembly is disclosed by Wijkamp et al. in U.S. Pat. No. 5,167,647. In one embodiment, a tubular strain relief is injection molded around one end of the catheter. After the strain relief has hardened, a hub is secured to the strain relief. Alternately, an end of the catheter may be inserted into a hub. The hub and catheter can then be placed into a mold to form the strain relief around the end of the catheter and between the catheter and the hub. Wijkamp et al. also discloses simultaneously molding both the hub and the strain relief from two different materials.
- Prichard et al., in U.S. Pat. No. 5,380,301, also disclose a prior hub assembly. Prichard et al. disclose a hub formed of a material having a relatively high durometer hardness in comparison to the catheter. The strain relief is preferably formed of a material having a flexibility and durometer hardness which is greater than that of the catheter, but less than that of the hub. The hub is first separately molded, then an end of the catheter is inserted into the hub. Then both the hub and the portion of the catheter proximal the hub are placed in a mold. As disclosed by Wijkamp et al., the strain relief is then molded around the catheter and between a portion of the hub and the catheter. The hub also includes openings into which molten strain relief material flows to form a mechanical bond between the strain relief and the hub.
- The present invention pertains to a hub assembly including an integrally formed hub and strain relief. The hub assembly can be insert molded in a single mold using one injection process and a single material. The material can be sufficiently hard for use in forming the hub. The desired relatively greater flexibility of the strain relief is achieved by modifying the geometry of the strain relief.
- In a preferred embodiment, the hub assembly in accordance with the present invention is for a catheter having a lumen therethrough. The hub assembly includes a hub portion having a proximal end and a distal end. An integral connection is disposed at the proximal end. A lumen defined through the hub portion extends from the proximal end to the distal end.
- A strain relief having a proximal end and a distal end is disposed at the distal end of the hub portion. The proximal end of the strain relief is integrally connected to the distal end of the hub portion. The strain relief defines a passage configured to receive the catheter such that the lumen through the hub portion is in fluid communication with the catheter lumen.
- The lumen extending through the hub includes a wall having an average wall thickness. The strain relief passage also has a wall having an average wall thickness. In a preferred embodiment, the average wall thickness of the hub portion is greater than the average wall thickness of the strain relief passage. In one embodiment, the wall thickness of the passage generally decreases from the strain relief proximal end toward the strain relief distal end.
- In a preferred embodiment, a plurality of grooves extend into the passage wall generally transversely toward the passage. The grooves can extend through the wall into the passage. The grooves can be disposed in a plurality of sets, each set including two grooves. The two grooves within each set can be disposed generally within the same plane to define a point of flexibility or transverse hinge in the strain relief. In an alternate embodiment, the strain relief can include a generally helical portion. The helical portion preferably extends from proximate the proximal end of the strain relief to proximate the distal end of the strain relief.
- In an alternate embodiment, the hub portion may include an angled port. The angled port, hub portion and strain relief portion can be integrally formed or connected by insert molding to form a manifold for an angioplasty catheter. The angled port defines a lumen in fluid communication with the lumen defined through the hub portion, and consequently the port is also in fluid communication with the lumen of the catheter tube held within the strain relief portion. If the angioplasty catheter is an over-the-wire catheter, a separate guide wire tube defining a guide wire lumen can extend through the catheter tube defining an inflation lumen between the catheter tube and the guide wire tube therein. The tube defining the guide wire lumen can include a separate hub portion connectable to the proximal end of the hub portion of the manifold.
- The connector can be a threaded connector. The hub portion can include transversely extending wings. The hub portion, the strain relief portion and angled port can be made from the same material, such as nylon, PEBA (polyether block amide polymer, commercially available under the trade name PEBAX), polycarbonate or another material having similar properties.
- FIG. 1 discloses a perspective view of a hub assembly in accordance with the present invention;
- FIG. 2 discloses a cross-section of the hub assembly of FIG. 1;
- FIG. 3 discloses a perspective view of an alternate embodiment of a hub assembly in accordance with the present invention;
- FIG. 4 discloses a perspective view of an alternative embodiment of the hub assembly in accordance with the present invention including an angled port forming a manifold;
- FIG. 5 discloses a perspective view of a hub for a guide wire tube insertable into the manifold of FIG. 4; and
- FIG. 6 discloses a perspective view of the manifold of FIG. 4 and the hub and guide wire tube of FIG. 5 inserted therein.
- Referring now to the drawings wherein like reference numerals refer to the same elements throughout the several views, a hub assembly in accordance with the present invention is referred to generally by
reference numeral 10 in FIG. 1.Hub assembly 10 is preferably connectable to an end of acatheter tube 12 which has alumen 14 extending therethrough.Catheter hub assembly 10 has an axial length defined along the section line 2-2 shown in FIG. 1. The proximal end ofhub portion 16 includes anintegral connector 18. Astrain relief 20 having aproximal end 22 anddistal end 24 is integrally connected atproximal end 22 to the distal end ofhub portion 16.Strain relief 20 preferably has a flexibility between that ofhub portion 16 andcatheter tube 12.Strain relief 20 includes apassage 26 which has alumen wall 27.Passage 26 extends fromdistal end 24 toproximal end 22.Passage 26 is configured to receive an end ofcatheter tube 12. -
Integral connector 18 ofhub portion 16 preferably includesthreads 28 for threadable connection to a Y-adaptor, inflation device or other devices as well known in the medical arts. Rather thanthreads 28,connector 18 could include a transversely extending flange, bayonets, or other connector means. -
Hub portion 16 preferably includes transversely extendingwings 30.Hub portion 16 can also include additional texturing provided by a raised portion such asrectangular print pad 32. An operator can push against the sides ofwing 30 to rotatehub assembly 10 to, for example, threadintegral connector 18 into a Y-adaptor or other device or rotatecatheter tube 12 for some therapeutic or diagnostic purpose. Similarly, the texturing orhub portion 16 provides a rough surface to assist an operator to griphub assembly 10. - Referring now to FIGS. 1 and 2,
strain relief 20 can includegrooves 36 extending transversely intostrain relief 20 towardpassage 26. The width and spacing ofgrooves 36 may be varied to effect the flexibility ofstrain relief 20.Grooves 36 may be arranged in transversely oppositely disposed sets of two, for example, grooves A and B. Each groove within a set can extend throughstrain relief 20 topassage 26 leaving athin portion 38 ofstrain relief 20 disposed between the oppositely disposedgrooves 36.Grooves 36 need not extend through topassage 26, but not extendinggrooves 36 through topassage 26 will reduce the flexibility ofstrain relief 20.Strain relief 20 is preferably more flexible atdistal end 24 than atproximal end 22. -
Thin portion 38 provides a point of flexibility or transverse hinge instrain relief 20. For example, as a generally transverse bending force is applied to strainrelief 20, grooves on the opposite side ofstrain relief 20 from the bending force will tend to close as grooves on the same side of the strain relief as the force tend to open. Because a bending force may be applied to any side ofstrain relief 20, it is preferable to vary the orientation ofgrooves 36 andthin portions 38 aroundstrain relief 20. For example, as shown in FIGS. 1 and 2, each successive set ofgrooves 36 is rotated 90° from the preceding set. - Referring now to FIG. 2, a
lumen 40 having aluminal wall 41 is shown extending from the proximal end to the distal end ofhub portion 16.Lumen 40 is in fluid communication withcatheter lumen 14. The extreme end ofcatheter tube 12 includes a transversely flaredportion 42 embedded inwall 41 oflumen 40. In a preferred embodiment ofhub assembly 10, to provide greater flexibility ofstrain relief 20 relative tohub portion 16, the average thickness ofwall 41 is greater than the average thickness ofstrain relief wall 27. The thickness ofwall 27 may also taper betweenproximal end 22 anddistal end 24 ofstrain relief 20. - FIG. 3 is a perspective view of an alternative embodiment of a
hub assembly 100 in accordance with the present invention.Hub assembly 100 includes ahub portion 102 having anintegral connector 104.Hub assembly 100 includes astrain relief 106 which has aproximal end 108 and a distal end 110 and a wall 111.Strain relief 106 is formed in a helical shape defining apassage 112 which is configured to receive an end of a catheter tube. The helix ofstrain relief 106 includes a series ofbends 114. Eachbend 114 is preferably spaced from theadjacent bend 114. The space between the bends provides a point of flexibility or hinge instrain relief 106. Other than thestrain relief 106,hub assembly 100 can in all respects be similar tohub assembly 10. The average thickness of strain relief wall 111 can be less than the average wall thickness of the lumen throughhub portion 102. - The hub assembly of the present invention may be modified by including an
angled port 200 to form amanifold 202.Manifold 202 includes ahub portion 204 having a proximal end and a distal end and anintegral connector 206 at the proximal end.Connector 206 can include two oppositely disposedtabs 208, each including anopening 210 therethrough. Integrally connected to the distal end ofhub portion 204 is astrain relief 212. Thestrain relief 212 includes an arrangement ofgrooves 214 substantially similar to the arrangement ofgrooves 36 ofstrain relief 20. -
Angled port 200 defines alumen 216 extending therethrough to alumen 218 extending throughhub 204. An end of acatheter tube 220 extends through apassage 222 defined bystrain relief 212 intolumen 218 ofhub portion 204. The extreme end oftube 220 can be anchored inhub portion 204 in the same manner as transversely flaredportion 42 ofhub assembly 10 described above. The end oftube 220 is anchored withinhub 204 distally of the opening oflumen 216 ofangle port 200 such that the lumen defined bytube 220 is in fluid communication withport lumen 216 andlumen 218 ofhub portion 204. - FIG. 5 shows a
hub 224 affixed to an end of aguide wire tube 226.Hub 224 includes alongitudinally extending lumen 228 in fluid communication with a guide wire lumen throughguide wire tube 226. The end oftube 226 withinhub 224 may be anchored like flaredend 42 ofhub assembly 10 described above.Hub 224 includes aninsertable portion 230 and two oppositely disposed bayonets 232 (one of which is hidden from view in FIG. 5). - As shown in FIG. 6,
guide wire tube 226 has been inserted intocatheter tube 220 throughhub portion 204 ofmanifold 202.Insertable portion 230 is inserted intolumen 218 ofhub portion 204 such thatbayonets 232 are inserted throughholes 210 oftabs 208 to connecthub 224 tomanifold 202. As known to those skilled in the art, in such a configuration, a guide wire can extend through the guide wire lumen,hub portion lumen 218 andhub lumen 228 for normal use. An inflation lumen in fluid communication withport lumen 216 is defined withincatheter tube 220 betweenguide wire tube 226 andtube 220. - The hub and manifold assemblies of the present invention are preferably integrally molded in one piece. The hub assembly is preferably formed by insert molding. In this process, a mandrel is inserted into the end of a catheter tube. A portion of the mandrel preferably extends from the end of the catheter tube. The catheter tube and mandrel are placed within the mold. Molten material is injected into the mold around the end of the catheter and the mandrel to form the integral hub assembly on the end of the catheter tube. Other standard molding techniques as well known in the art may be used to integrally mold the hub assembly of the present invention.
- Material such as PEBA (polyether block amide polymer, commercially available under the trade name PEBAX), Isoplast or other polyurethanes, nylon, polycarbonate, ULTEM, polyester polycaprolactone, and high density polyethylene or similar material may be used to form the hub and manifold assemblies of the present invention. Depending upon the specific use of the hub assembly, the flexural modulus of the material to be used is preferably between 60,000 and 500,000 psi. However, materials having a higher or lower flexural modulus can be used depending upon the particular application for the hub assembly. For example, materials having a higher flexural modulus can be used with a relatively stiff catheter tube whereas materials having a lower flexural modulus can be used with relatively more flexible catheter tubes.
- Numerous characteristics and advantages of the invention covered by this document have been set forth in the foregoing description. It will be understood, however, that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of parts without exceeding the scope of the invention. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
Claims (26)
1. A hub assembly for a catheter tube having a lumen therethrough, the hub assembly comprising:
a hub portion having a proximal end and a distal end, and including an integral connection disposed at the proximal end, and a lumen defined therethrough extending from the proximal end to the distal end; and
a strain relief having a proximal end and a distal end, the strain relief being disposed at the distal end of the hub portion and the proximal end of the strain relief being integrally connected to the distal end of the hub portion, the strain relief defining a passage configured to receive the catheter tube such that the lumen through the hub portion is in fluid communication with the catheter lumen.
2. A hub assembly in accordance with , wherein the lumen extending through the hub portion has a wall having an average wall thickness and the strain relief passage has a wall having an average wall thickness, and the average wall thickness of the hub portion is greater than the average wall thickness of the strain relief passage.
claim 1
3. A hub assembly in accordance with , wherein the wall thickness of the passage generally decreases from the strain relief proximal end to the strain relief distal end.
claim 2
4. A hub assembly in accordance with , wherein a plurality of grooves extend into the passage wall generally transversely toward the passage.
claim 3
5. A hub assembly in accordance with , wherein the grooves extend through the wall into the passage.
claim 4
6. A hub assembly in accordance with , wherein the grooves are disposed in a plurality of sets, each set including two grooves, the two grooves within each set being disposed generally within the same plane to define a transverse hinge in the strain relief.
claim 4
7. A hub assembly in accordance with , wherein the strain relief includes a generally helical portion extending from proximate the proximal of the strain relief to proximate the distal end of the strain relief.
claim 3
8. A hub assembly in accordance with , wherein the connector is a threaded connector.
claim 1
9. A hub assembly in accordance with , wherein the hub portion includes transversely extending wings.
claim 1
10. A hub assembly in accordance with , wherein the hub portion and the strain relief portion comprise the same material.
claim 1
11. A hub assembly in accordance with , wherein the material comprises nylon.
claim 10
12. A hub assembly in accordance with , wherein the material comprises PEBA.
claim 10
13. A hub assembly in accordance with , wherein the material comprises polycarbonate.
claim 10
14. A hub assembly in accordance with , further comprising:
claim 1
an angled port integrally connected to, and extending from, the hub portion.
15. A hub assembly for a catheter tube having a lumen therethrough, the hub assembly comprising:
a hub portion having a proximal end and a distal end, and including an integral connection disposed at the proximal end, and a lumen defined therethrough extending from the proximal end to the distal end; and
a strain relief having a proximal end and a distal end, the strain relief being disposed at the distal end of the hub portion and the proximal end of the strain relief being integrally connected to the distal end of the hub portion, the strain relief being more flexible than the hub portion, the strain relief defining a passage including a wall, the passage configured to receive the catheter tube such that the lumen through the hub portion is in fluid communication with the catheter lumen.
16. A hub assembly in accordance with , wherein a plurality of grooves extend into the passage wall generally transversely toward the passage.
claim 15
17. A hub assembly in accordance with , wherein the grooves extend through the wall into the passage.
claim 16
18. A hub assembly in accordance with , wherein the grooves are disposed in a plurality of sets, each set including two grooves, the two grooves within each set being disposed generally within the same plane to define a transverse hinge in the strain relief.
claim 16
19. A hub assembly in accordance with , wherein the strain relief includes a generally helical portion extending from proximate the proximal end of the strain relief to proximate the distal end of the strain relief.
claim 15
20. A hub assembly in accordance with , wherein the connector is a threaded connector.
claim 15
21. A hub assembly in accordance with , wherein the hub portion includes transversely extending wings.
claim 15
22. A hub assembly in accordance with , wherein the hub portion and the strain relief portion comprise the same material.
claim 15
23. A hub assembly in accordance with , wherein the material comprises nylon.
claim 22
24. A hub assembly in accordance with , wherein the material comprises PEBA.
claim 22
25. A hub assembly in accordance with , wherein the material comprises polycarbonate.
claim 22
26. A hub assembly in accordance with , further comprising:
claim 15
an angled port integrally connected to, and extending from, the hub portion.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/888,920 US20010049519A1 (en) | 1995-06-05 | 2001-06-25 | Integral hub and strain relief |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US46186795A | 1995-06-05 | 1995-06-05 | |
US08/971,456 US6273404B1 (en) | 1995-06-05 | 1997-11-17 | Method of making monolithic hub and strain relief |
US09/888,920 US20010049519A1 (en) | 1995-06-05 | 2001-06-25 | Integral hub and strain relief |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US08/971,456 Continuation US6273404B1 (en) | 1995-06-05 | 1997-11-17 | Method of making monolithic hub and strain relief |
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US20010049519A1 true US20010049519A1 (en) | 2001-12-06 |
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Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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US08/971,456 Expired - Lifetime US6273404B1 (en) | 1995-06-05 | 1997-11-17 | Method of making monolithic hub and strain relief |
US09/888,920 Abandoned US20010049519A1 (en) | 1995-06-05 | 2001-06-25 | Integral hub and strain relief |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
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US08/971,456 Expired - Lifetime US6273404B1 (en) | 1995-06-05 | 1997-11-17 | Method of making monolithic hub and strain relief |
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US20070099485A1 (en) * | 2005-10-31 | 2007-05-03 | Hon Hai Precision Ind. Co., Ltd. | Cable with strain relief |
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Legal Events
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AS | Assignment |
Owner name: BOSTON SCIENTIFIC SCIMED, INC., MINNESOTA Free format text: CHANGE OF NAME;ASSIGNOR:SCIMED LIFE SYSTEMS, INC.;REEL/FRAME:018505/0868 Effective date: 20050101 Owner name: BOSTON SCIENTIFIC SCIMED, INC.,MINNESOTA Free format text: CHANGE OF NAME;ASSIGNOR:SCIMED LIFE SYSTEMS, INC.;REEL/FRAME:018505/0868 Effective date: 20050101 |
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STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |